| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Proposed |
| Created: | 27.02.2018 10:50:01 |
| Modified: | 16.09.2019 16:14:39 |
| Advanced : | |
| Appears In: | Do / update clinical evaluation |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
Clinical Marketing- CA_Clinical Affairs
- CA_Clinical Affairs
«BusinessProcess» Appraisal of individual data sets
«BusinessProcess» Do clinical study forecast- «BusinessProcess» Manage clinical study
- «BusinessProcess» Perform clinical study based on CIP
- «BusinessProcess» Do AE surveillance
- «BusinessProcess» Do / update clinical evaluation
- Do / update clinical evaluation
«Activity» Analysis, merging and conclusion of relevant data- «Activity» Assess clinical aspects to be considered
- «Activity» Create clinical evaluation report
- «Activity» Generate clinical evaluation strategy
- «Activity» Identify clinical data
«StartEvent» Article
«EndEvent» Clinical evalution done
«Gateway» Is clinical evidence sufficient to be able to declare conformity with relevant Essential Requirements?
- «BusinessProcess» Apply for clinical validation
- «BusinessProcess» Prepare and apply for clinical study
- CAM_Clinical Application Management
- MC_Marketing & Communications
- PM_Product Management
- TW_Technical Writing
- «BusinessProcess» Manage compentencies CM
- «BusinessProcess» Manage tools and equipment CM
- «BusinessProcess» Plan resources and budget CM
- «BusinessProcess» Report CM
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox